DEXA Bone Density Analysis of the CoreHip® Prosthesis System (CODEX)

Aesculap

Status

Not yet enrolling

Conditions

Osteonecrosis of Femoral Head

Traumatic Disorder

Osteoarthritis, Hip

Cartilage Degeneration

Inflammatory Arthritis

Primary Osteoarthritis

Treatments

Device: Primary hip replacement with cementless stem

Study type

Interventional

Funder types

Industry

Identifiers

NCT06632301

AAG-G-H-23009

Details and patient eligibility

About

The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.

Full description

Additional diagnostic examination: DEXA-Analysis. A DEXA scan is an imaging test that measures bone density (strength). The results can provide helpful details about risk for osteoporosis (bone loss) and fractures. Furthermore we would like to find out more about stress shielding processes around our prosthesis.

Enrollment

40 estimated patients

Sex

All

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Unilateral hip osteoarthritis
Indication for CoreHip Standard hip stem according to preoperative planning
Written Informed Consent
Age 35-85 years
According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits

Exclusion criteria

Femoral neck fractures
Pregnancy
BMI > 35
History of femoral fracture or previous surgery on the same hip
Metabolic bone disease, use of steroids or other drugs affecting bone metabolism
Intraoperative bone cracks
Severe osteoarthritis of the contralateral hip
THA of the contralateral side or other event leading to restricted weight bearing during the study period